BeNeLuxBelgiumNetherlandsLuxembourg

FDA rejects Rhucin BLA and asks for additional clinical data

01.03.2011

Leiden/San Diego – Bad news for the Dutch Pharming Group and its partner Santarus Inc, who wants to market the heriditary angioedema treatment Rhucin (INN conestat alfa) in North America – the FDA said on Monday, that the companies’ BLA submitted in December was not sufficiently complete to enable a critical medical review of the EU approved recombinant human C1 inhibitor that is produced in milk of transgenic rabbits. In its „refusal to file” letter, the FDA said that the studies submitted had a insufficient number of subjects to support the proposed dose and lacked prospective validation of the visual analog scale used in measuring the clinical effects of the drug. The FDA asked to include the data of an ongoing Phase IIIb clinical study in any future BLA submission for Rhucin. Under the terms of the partnership, Pharming will be responsible for conducting and paying for the current Phase IIIb clinical study with Rhucin (Ruconest),. The drug was recommended in Europe after doubts about its efficacy. Rhucin is also under development for follow-on indications, i.e. antibody-mediated rejection (AMR) and delayed graft function (DGF) following kidney transplantation.




BeNeLuxBelgiumNetherlandsLuxembourg

06.10.2011

Hamburg/Brussels - Evotec AG and UCB Pharma seem to be satisfied with their relationship. The Belgian pharmaceutical company entered into a second multi-year, multi-target integrated drug discovery collaboration with Evotec in...

BeNeLuxBelgiumNetherlandsLuxembourg

05.10.2011

Luxembourg - For its tiny size, Luxembourg attracts a disproportionally huge amount of venture capital. Creabilis SA has raised €15m in a Series B funding round led by Abbott Biotech Ventures. "In Abbott, we have added another...

BeNeLuxBelgiumNetherlandsLuxembourg

01.10.2011

Munich/Amsterdam – Researchers from the LMU Munich and the Aca­demic Medical Center Amsterdam have found a way to predict disease outcome in patients with life-threatening bacterial meningitis. In a nation­wide genetic...

BeNeLuxBelgiumNetherlandsLuxembourg

01.10.2011

Utrecht – Consuming fish or fish oil capsules may be a bad idea for cancer patients, according to Dutch researchers. In mid-September, a team headed by Emile Voest from the University Medical Centre Utrecht reported such products...

BeNeLuxBelgiumNetherlandsLuxembourg

01.10.2011

Rotterdam – Finnish oil refining company Neste Oil corporation has kick-started production in Europe’s largest renewable diesel refinery in Rotterdam. The plant has a capacity of 800,000 tonnes a year, and this will be ramped up...

BeNeLuxBelgiumNetherlandsLuxembourg

01.10.2011

Brussels – A European gateway to life science capacities has been launched (www.toolsofscience.eu) that is aimed at providing a novel resource for identifying the best facilities and service companies from among 13 bioregions...

BeNeLuxBelgiumNetherlandsLuxembourg

01.10.2011

Stockholm/Leiden/Barcelona – A complicated ménage a trois has come to an end: Swedish Orphan Biovitrum AB, Pharming Group N.V. and Esteve S.A. announced at the beginning of September that they were terminating a 2004 deal...

BeNeLuxBelgiumNetherlandsLuxembourg

14.09.2011

Bunnik – AM-Pharma B.V. has raised €29.2m. The Dutch company plans to spend the money on delivering a human recombinant form of Alkaline Phosphatase (AP) as a treatment for Acute Kidney Injury (AKI) from preclinical stages to the...

BeNeLuxBelgiumNetherlandsLuxembourg

13.09.2011

Utrecht – Researchers at University Medical Center Utrecht have dealt a blow to the advocates of allegedly healthy fish oil. The substance which is again and again named as a helpful substance for cancer patients, seems instead...

Displaying results 21 to 30 out of 304

< Previous 21-30 Next >

© 2007-2014 BIOCOM

http://www.european-biotechnology-news.com/nc/news/messages-archive/archive-benelux/browse/2/article/fda-rejects-rhucin-bla-and-asks-for-additional-clinical-data.html

Print Magazine

Product of the week

Products

Events

All Events

Stock list

All quotes

TOP

  • THERAMETRICS0.08 CHF14.29%
  • CYTOS0.17 CHF13.33%
  • MORPHOSYS75.99 EUR4.89%

FLOP

  • EPIGENOMICS4.15 EUR-4.38%
  • EVONIK26.20 EUR-2.42%
  • PAION2.80 EUR-2.10%

TOP

  • BIOFRONTERA2.82 EUR28.2%
  • HBM91.50 CHF8.6%
  • EPIGENOMICS4.15 EUR8.4%

FLOP

  • MAGFORCE5.55 EUR-19.6%
  • CO.DON2.65 EUR-15.6%
  • PAION2.80 EUR-13.0%

TOP

  • SANTHERA89.00 CHF2318.5%
  • CO.DON2.65 EUR167.7%
  • WILEX2.25 EUR81.5%

FLOP

  • CYTOS0.17 CHF-95.7%
  • MERCK KGAA71.68 EUR-41.5%
  • 4SC0.98 EUR-41.0%

No liability assumed, Date: 30.10.2014

Current issue

All issues